FDA UDI
In Commercial Distribution
🇺🇸 United States
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
DI: 07290008960267
·
Model: E-560-0 / E-561-0
·
SHL TELEMEDICINE INTERNATIONAL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
- Primary DI
- 07290008960267
- Version / Model
- E-560-0 / E-561-0
- Company Name
- SHL TELEMEDICINE INTERNATIONAL LTD.
- Labeler DUNS
- 531817906
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-22
- Public Version
- 1
- Public Version Date
- 2023-08-30
- Public Version Status
- New
- Public Device Record Key
- 4752d3fc-7d8c-4d67-a947-b699a870c10e
Device Description
The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | Cardiovascular | 870.2920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62641 | Electrocardiograph, home-use | A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290008960267 | GS1 |
Customer Contacts
- Phone
- +97235612212
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063609 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 90 | Millimeter | |
| Width | 75 | Millimeter | |
| Depth | 30 | Millimeter | |
| Weight | 200 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 45 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal